NCT05687032CompletedPhase 4
A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
A PHASE 4, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY OF INOTUZUMAB OZOGAMICIN IN CHINESE ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)
Source: ClinicalTrials.gov · Last updated 3 Dec 2025
Brief summary (registry, in English)
This is an open-label, single-arm, multicenter study in Chinese patients with relapsed or refractory CD22-positive B-cell ALL. The objective of the study is to confirm the efficacy, safety, and PK of inotuzumab ozogamicin in patients with relapsed or refractory B-cell ALL from mainland China.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 6 Jan 2023
- Start date
- 24 Feb 2023
- Primary completion date
- 7 Aug 2024
- Lead sponsor
- Pfizer
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT05687032
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 44
- From 24 Feb 2023 to the primary completion date, 7 Aug 2024
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior allogeneic hematopoietic stem cell transplant (HSCT) or other anti-CD22 immunotherapy within 4 months, or active graft versus host disease (GvHD) at study entry.
Other illness
- Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).
Other
- Subjects with isolated extramedullary relapse or active central nervous system (CNS) leukemia.
Who the study is looking for
- Male or female participants, age 18 years or older at screening.
- Relapsed or refractory CD22-positive ALL.
- Subjects with Philadelphia chromosome-positive (Ph+) ALL must have failed standard treatment with at least one tyrosine kinase inhibitor.
- Patients in Salvage 1 with late relapse should be deemed poor candidates for reinduction with initial therapy.
- Patients with lymphoblastic lymphoma and bone marrow involvement ≥5% lymphoblasts by morphologic assessment.
- ECOG performance status 0-2.
- Adequate renal and hepatic function, and negative pregnancy test for women of childbearing potential.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Nanfang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangzhou First People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Hospital of Harbin Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical College Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Union Hospital, Tongji Medical College of Huazhong University of Science & Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.